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Instructions on how to use this template

  1. Copy QS Template page and move to the Initial development (not ready for review) page. Please DO NOT OVERWRITE the template pages.
    1. If the supplement is based on a measurement system, such as PRO-CTCAE V1.0, FACIT, PROMIS, etc., replace the word instrument with measurement system throughout the supplement.
  2. The "–" in this template represents the domain implemented for the instrument. This is replaced with the 2-character domain abbreviation of FT, QS, or RS that is used for the instrument.
  3. Change the title of the page as follows:
    1. Remove 'Copy of QRS Supplement Template - '.
    2. Replace 'Name of QRS Instrument' with the full name of the QRS instrument the supplement is being created for.
    3. Change 'QRS Short_Name' to the short name (--CAT) for the current instrument.
  4. Update the information in the Page Properties block below as indicated in the block below.
    1. The supplement version number in the header section will be 'v1' if there has never been a supplement for the instrument before. Otherwise, increment as appropriate.
    2. If the CRF was copyright approved, keep 'Approved'; otherwise change 'Approved' to 'Public Domain'.
  5. Replace 'Title' and 'QRS Short_Name' throughout the document with the title and short name of the instrument that the supplement is being created for.
  6. Replace royal blue text with information pertaining to the instrument the supplement is being created for. Delete royal blue text which does not apply to the new instrument.
  7. Unless otherwise noted, text in black applies to all QRS Supplements and should not be deleted, but should be examined carefully and revised as appropriate based on the specific instrument supplement as needed. Any changes need to be in blue font to stand out for review.
  8. Change QS to RS or FT and 'Questionnaires' to 'Disease Response and Clin Classification' or 'Functional Tests' as appropriate.
  9. Remove all information blocks, except for the one immediately below this called 'Information for Reviewers'.
  10. Keep changes in blue for ease throughout internal and public review. Once the supplement has gone thru public review and all comments are resolved, change all text color to black except for hyperlinks.
  11. Arabic numerals (0, 1, 2, 3, etc.) are used to express numbers in most circumstances. Exceptions are the following: 
    • Numbers that begin a sentence, title, subtitle, or heading 
    • Common fractions 

    • Accepted usage such as idiomatic expressions and numbers used as pronouns 

    • Other uses of “one” in running text (e.g., when meaning "a")
    • Ordinals first through ninth
    • Numbers spelled out in quotes or published titles.

Information for Reviewers

Text in black is part of the template used to create this document and is not revised under CDISC internal or public review. Please review the blue text; this text represents the changes made to the template that are specific to this QRS instrument.

Title

Name of QRS instrument (QRS Short_Name)

CDISC ReferenceQuestionnaire (or 'Clinical Classification' or 'Functional Test', as appropriate) Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials
QRS Short Name

QRS Short_Name

QRS Permission StatusApproved (or 'Public Domain, Exempt from Copyright', as appropriate)
TeamStandards team QRS instrument is being developed for (e.g., Major Depressive Disorder Standards Team), if applicable, and CDISC Questionnaires, Ratings, and Scales (QRS) Subteam
Supplement Version1.0 (or higher as appropriate when doing a supplement revision)
StatusDRAFT (or "REVISION DRAFT" or "FINAL", as appropriate). Status will not be considered "Final" until the supplement is ready to be sent for publication.
Dateyyyy-mm-dd (date current version released, regardless of status - this date should always match the date in the Revision History section below and should be updated every time this supplement is edited.)
Notes to Readers
  • This supplement is available to be used with other CDISC user guides for specific therapeutic/disease areas and follows the CDISC Study Data Tabulation Model Implementation Guide for Human Clinical Trials.
  • This instrument is a US FDA Qualified Clinical Outcome Assessment (COA) instrument. (COA #XXX, Qualified Clinical Outcome Assessments (COA) | FDA) (Use only for instruments this applies to; update COA #.)
Known IssuesOnly include this row to describe any known issues related to the supplement. If there are no issues, this row can be deleted.


Revision History

DateVersion
2023-mm-dd1.0 Draft

© 2023 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

For the first version of a supplement, use the above Revision History table and delete this information box.

When a previously published supplement is being revised, a modified "Revision History" table will need to be used. Add a new column at the right called "Summary of Changes" if this is the first revision to the supplement (see table below). Also add a new row under the column headers with the current information, keeping all rows previously added. The bottom row should be for Version 1.0, with subsequent versions added above each of the previous rows.

If you are making changes to a supplement for the first time, put "Initial Final Version" in the Summary of Changes column for Version 1.0. Then add a row above with the new version number (1.1 if the changes are considered minor such as a typo, 2.0 if they are major such as variable changes) and summary of changes.


Revision History

DateVersionSummary of Changes
2023-mm-ddx.x (e.g., 1.1, 2.0)xxx
2019-mm-dd1.0Initial Final Version

© 2023 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

1 Introduction

This document describes the CDISC implementation of the Title instrument.

For CRFs that are NOT created by CDISC, use this statement:  CDISC did not modify this questionnaires, ratings, and scales (QRS) instrument to meet Clinical Data Acquisition Standards Harmonization (CDASH) case report form (CRF) standards.

For CRFs that are created by CDISC with SME input, use this statement:  There is no known standard case report form (CRF) available for this instrument. CDISC created this CRF to represent the instrument, which CDISC believes is in the public domain. This is not an endorsement of the instrument. The creation of this instrument was based on input from PASI (TA or instrument) subject matter experts. Sponsors may create this instrument’s CRF using their style guidelines, but they need to maintain the wording and order of the questions/items and responses as described on the CRF.  (note that if you use this statement, then QRS is not spelled out for the first time until where noted below.) (the related reference article needs to be included as a footnote on the CDISC created CRF)

For CRFs that are created by CDISC based on articles, use this statement. Include the 1st sentence for articles that don't have a CRF.  If the 1st sentence is NOT included, then spell out "case report form (CRF)" in the 2nd sentence:  There is no known standard case report form (CRF) available for this instrument. CDISC created this CRF to represent the instrument, which CDISC believes is in the public domain. This is not an endorsement of the instrument. The creation of this instrument was based on published articles describing the instrument. Sponsors may create this instrument’s CRF using their style guidelines, but they need to maintain the wording and order of the questions/items and responses as described on the CRF.  (note that if you use this statement, then QRS is not spelled out for the first time until where noted below.)

The representation of data collected for this instrument is based on the Study Data Tabulation Model Implementation Guide (SDTMIG) Questionnaires (QS) domain model, which can be found on the CDISC website at: https://www.cdisc.org/standards/foundational/sdtmig.

The specific implementation details for this instrument are meant to be used in conjunction with the SDTMIG. All CDISC QRS (spell out "questionnaires, ratings, and scales" if this is a CDISC-created CRF and put QRS in parentheses.) documentation packages can be found on the CDISC website at: https://www.cdisc.org/standards/foundational/qrs.

The CDISC Intellectual Property Policy can be found on the CDISC website at: https://www.cdisc.org/about/bylaws.

1.1 Representations and Warranties, Limitations of Liability, and Disclaimers

This document is a supplement to the SDTMIG for Human Clinical Trials and is covered under Appendix F of that document, which describes representations, warranties, limitations of liability, and disclaimers. Please see Appendix F of the SDTMIG for a complete version of this material.

CDISC specifies how to structure the data that has been collected in a database, not what should be collected or how to conduct clinical assessments or protocols. CDISC disclaims any liability for your use of this material.

Although the United States Food and Drug Administration (US FDA) has provided input with regard to this supplement, this input does not constitute US FDA endorsement of any particular instrument.  (Include this line only for supplements that the US FDA will be reviewing.  Please DO NOT MODIFY the sentence.)

2 Copyright Status

For copyrighted instruments use the following text:  Name of copyright holder (e.g., Board of Regents of The University of Texas System) owns the copyright for the QRS Short_Name instrument and has granted CDISC permission to include this supplement in the CDISC inventory of QRS data standards supplements. (For supplements that are to be distributed by the copyright holder, add: Name of copyright holder (e.g., Board of Regents of The University of Texas System) will distribute the CDISC supplement package to sponsors when they are approved to use this instrument.) Hence, CDISC developed QSTESTCD and QSTEST for each item based on the actual text on the instrument.

For public domain instruments use the following text: CDISC believes this instrument to be in the public domain, but you should perform your own assessment. CDISC has included the QRS Short_Name in the CDISC inventory of QRS data standards supplements. Hence, CDISC developed QSTESTCD and QSTEST for each item based on the text on the instrument. There may be many versions of this instrument. CDISC has chosen to use this version as the data standard.

Insert the CDISC copyright or Exempt from Copyright CDISC text that is included in each of the –CAT CT CDISC Definition. This same text is annotated as a text box on the annotated CRF.

These materials discuss and/or include one or more of the SF Health Surveys, which are owned exclusively by QualityMetric Incorporated. No part of the SF Health Surveys may be reproduced, distributed, or transmitted in any form or by any means, including photocopying, recording, or other electronic or mechanical methods, without the prior written permission of QualityMetric Incorporated and payment of any applicable fees. Copyright QualityMetric Incorporated All rights reserved.

These materials discuss and/or include the Patient Health Questionnaire - 9 (PHQ-9) which is owned exclusively by the Pfizer. Inc. Use of the PHQ-9 is subject to Pfizer. Inc. terms of use. See (https://www.phqscreeners.com/select-screener). PHQ-9 copyright 2001, Pfizer. Inc.

The CDISC documentation of this instrument consists of: (1) controlled terminology, (2) standard database structure with examples, and (3) CRF(s) annotated with the CDISC SDTMIG variables with submission values. 

Information for Reviewers

The CRF is attached at the top of the Wiki. When you click the paperclip image, you will find the file for the annotated CRF.

Note: CDISC Controlled Terminology is maintained by National Cancer Institute (NCI) Enterprise Vocabulary Services (EVS). The most recent version should be accessed through the CDISC website at: https://www.cdisc.org/standards/terminology/controlled-terminology.

Include the following statements as standalone paragraphs for copyrighted instruments:

CDISC has developed this documentation at no cost to the copyright holder or any additional cost to users of the instrument beyond the normal license fees charged by the copyright holder.

CDISC acknowledges [insert the name of the copyright holder, in blue text] (e.g., Dr. A. J. Rush, at the UT Southwestern Medical Center) for the approval to include the QRS Short_Name in the CDISC data standards.


Only include the actual references and all material used in developing the supplement on the reference section below. This should be a reference paper or a website reference in place of a paper.

Reference for the QRS Short_Name:

Rush, A.J., Carmody, T. and Reimitz, P.E. The Inventory of Depressive Symptomatology (IDS): Clinician (IDS-C) and self-report (IDS-SR) ratings of depressive symptoms. International Journal of Methods in Psychiatric Research, 9:45-59, 2000. 

This is an example only.  Use the reference from the CDISC definition of the --CAT.

  • do not include the parentheses.
  • do not include copyright information from the definition about copyright holder and version since that's already included above.
  • do add a period to the end

If there are multiple references, please use the following format:

References for the QRS Short_Name:

  • CDISC Controlled Terminology reference.
  • additional reference.

Notes on the use of quotation marks:

  • Use for text values of a Likert scale: e.g., ...with response options ranging from “never” to “daily."
  • Actual numbers of the scale (e.g., 0-3) do not appear in quotation marks while the definitions of these anchors (e.g., 5 = “I always fall asleep”) do.
  • Enclose values for variables within quotation marks (e.g., QSTESTCD = "IPA0102")


3 The QS Domain Model

3.1 Assumptions for the QS Domain Model

All assumptions and business rules described in the SDTMIG QS domain are applicable to this supplement. Additional assumptions specific to the QRS Short_Name are listed below.

The QRS Short_Name is a multiple-choice instrument that clinicians may use to assess the severity of depressive symptoms. It consists of 30 items, each rated on a 4-point scale. A total score between 0-84 is also captured.

  1. Include a description of scale score or other possible responses (You may need multiple numbered points for this, though the IDS-SR did not.). For scale scores use the following language: The scale points include a numeric rating (0-3) and a definition of what is represented by the rating (e.g., 0 = "I never take longer than 30 minutes to fall asleep"). For the QRS Short_Name, QSORRES is populated with the text description while the numeric rating is represented in the standardized character and numeric result variables QSSTRESC and QSSTRESN. (Replace this sentence for instruments with text only responses with “QSORRES and QSSTRESC are populated with the text description and QSSTRESN is not represented with a numeric value”.

  2. Include a description of the evaluation interval if one exists. This may be numeric (QSEVLINT) or text (QSEVINTX). When the evaluation interval is provided in text and cannot be described in ISO 8601 format, use QSEVINTX instead of "QSEVLINT field in ISO 8601 format" and replace "the past 7 days" with the text (e.g., "DAYTIME'". Refer to SDTMIG Section 2.2.5 Timing Variables for All Classes). The evaluation interval needs to be clearly defined on the CRF. Remove this point if it does not apply.: 

    1. If numeric use this wording: The time period of evaluation for the QRS Short_Name is populated in the --EVLINT field in ISO 8601 format when the evaluation interval can be precisely described as duration. The evaluation interval for the QRS Short_Name is the past 7 days (--EVLINT = "-P7D")

    2. If text use this wording: The time period of evaluation for the QRS Short_Name is populated in the --EVINTX field as an evaluation interval text value, since it cannot be precisely described as an ISO 8601 duration. The evaluation interval for the QRS Short_Name is "LIFETIME" (--EVINTX = "LIFETIME").
  3. If there are subcategories, include a note that subcategories will be represented in QSSCAT. Also provide a list of the subcategories unless one is already provided in the description preceding the assumptions. Remove this point if it does not apply.  For example:  Items are divided into 5 subcategories represented in QSSCAT: "PHYSICAL WELL-BEING", "SOCIAL/FAMILY WELL-BEING", "EMOTIONAL WELL-BEING", "FUNCTIONAL WELL-BEING", and "ADDITIONAL CONCERNS".
  4. Records are created in qs.xpt for every instrument item

    1. For items with no data, QSORRES, QSSTRESC, and QSSTRESN are all missing and QSSTAT = "NOT DONE". If the reason is known then that reason is represented in QSREASND (e.g., QSREASND = "PREFER NOT TO ANSWER"). If the reason is unknown, then QSSTAT = "NOT DONE" and QSREASND is missing.

    2. Due to the variability of copyright holder and public domain derived score generation processes, records are not included for derived subscores or total scores that are not provided.
  5. If the instrument standards currently being developed includes conditionally branched items, insert: Some items on the QRS Short_Name may be conditionally branched per the instrument instructions. Only one of the 2 oxygen saturation scales (RSTESTCD = "NEWS102" or "NEWS103") is completed for each subject. The other will be treated as a conditionally branched item. In addition, item RSTESTCD = "NEWS104A" is only completed when the response to RSTESTCD = "NEWS104" is the amount of oxygen received (in L/min). A record is created in rs.xpt for all items. When an item is considered a conditionally branched item, it is represented as follows:

    When assigned conditionally branched responses are not documented in the instrument’s instructions or a user manual:

    1. QNAM = “QSCBRFL”, QLABEL = “Conditional Branched Item Flag “, QVAL = “Y” (this is a QS supplemental qualifier variable related to the record).
    2. QSORRES, QSSTRESC, and QSSTRESN are set to null (missing).

    When assigned conditionally branched responses are documented in instructions or a user manual:

    1. QNAM = “QSCBRFL”, QLABEL = “Conditional Branched Item Indicator“, QVAL = “Y” (this is a QS supplemental qualifier variable).
    2. The QSORRES responses are represented as follows:
      1. For severity items, QSORRES = "None".
      2. For interference items, QSORRES = "Not at all".
    3. If numeric response values are assigned, they are represented here: QSSTRESC = 0 and QSSTRESN = 0.

       or If no numeric responses are assigned: QSSTRESC = NULL and QSSTRESN = NULL.

  6. Include this point if score(s) are submitted to SDTM. Update blue text: The QRS Short_Name instrument includes a total score (and subscores or other scores as needed.  If so, change "that is" to "that are") that is considered as captured data on the instrument and is not considered as derived in the example below. These scores may be submitted in SDTM or derived in the Analysis Data Model (ADaM) per scoring instructions from [Insert copyright holder's name or other source.].

    1. Subtotal and total scores are represented in--ORRES, --STRESC, and --STRESN.
    2. If scores are received or derived by the sponsor, it is recommended that they are submitted to SDTM and verified in ADaM whenever feasible.
  7. Please review the decision on not including –EVAL and --EVALID in the QRS Supplement Best Practices topic “--EVAL/–EVALID not included in QRS domains/datasets”. Now we only represent administrative information if it is explicitly collected on an instrument. No assumptions are made for this data; if it's not on the instrument, it's not in the data.

    The SUPPQUAL variables used are a series of non-standard variables that represent collected administrator information, administration device, etc., and these updated SUPPQUAL variables are included in the WIKI non-standard variable registry (Non-standard Variable Registry). For example:

    1. PPRAID which is "Preprinted Administrator Identifier".
    2. COLAVL which is "Collected Administrator Value".

    The supplement version 1.0 of the FAS-NACC UDS V3.0 instrument shows an implementation example.

    The QRS Short_Name instrument collects administrative information as the preprinted examiner’s initials and the collected response. This is represented in the SUPPQUAL variable QNAM = --PPRAID” with QNAM = “Preprinted Administrator Identifier” and QVAL = “EXAMINER’S INITIALS”. The collected initials response is represented with QNAM = “--COLAID” and QNAM = “Collected Administrator Identifier” and QVAL = “ADM1”.

    This is part of the data example for the SUPPQUAL variables.

    The SUPPRS table represents the preprinted and collected administrative items represented on the CRF. 

     supprs.xpt

    STUDYID

    RDOMAIN

    USUBJID

    IDVAR

    IDVARVAL

    QNAM

    QLABEL

    QVAL

    QORIG

    STUDYX

    RS

    100-10001

    RSCAT

    FAS-NACC UDS V3.0

    RSPPRAID

    Preprinted Administrator Identifier

    EXAMINER'S INITIALS

    CRF

    STUDYX

    RS

    100-10001

    RSCAT

    FAS-NACC UDS V3.0

    RSCOLAID

    Collected Administrator Identifier

    ADM1

    CRF

  8. Include this point if there are comments at the end of the instrument. Remove this point if it does not apply.: Comments located at the end of the QRS Short_Name will be recorded in the Comments domain (CO). All assumptions and business rules described in the SDTMIG CO domain are applicable.

  9. Include this point if there are responses over 200 characters. Remove this point if it does not apply: Some responses to the QRS Short_Name items exceeded the 200-character limit for the QSORRES variable and needed to be reduced to fewer than 200 characters. Section 4, SDTM Mapping Strategy, indicates which item responses were revised in order to fit the 200-character limit.

  10. Terminology

    1. QSCAT, QSTESTCD, QSTEST, QSORRES, QSSTRESC, and QSSTRESN (and other variables such as QSORRESU as needed; only include QSORRES, QSSTRESC, and QSSTRESN if the responses are published in CT with public domains instruments) values are included in CDISC Controlled Terminology.

    2. A full list of value sets for the qualifier, timing, resultand unit fields is provided in Section 4, SDTM Mapping Strategy. (Note: Only the result field is always used. Include qualifier, timing, and unit fields as needed and remove this note.)

3.2 Example for the QRS Short_Name QS Domain Model

The QRS Short_Name example below shows the terminology used to implement the instrument in the QS domain. This example shows the data for 1 subject collected at the baseline visit for the QRS Short_Name instrument. The example uses CDISC Controlled Terminology for QSTESTCD, QSTEST, and QSCATAll original results, matching the CRF item response text, are represented in QSORRES. When there are numeric results, then use this sentence next, "This result is then represented as a standard numeric score in QSSTRESN and as a standard character representation in QSSTRESC." When the results are character only, then use these sentences next, "This result is then transformed into the standard character representation in QSSTRESC. QSSTRESN is null as there are no standardized numeric results for this instrument."


Update the data in the table below to the current instrument. Include row descriptions as needed to highlight idiosyncrasies or items otherwise of note in this particular instrument. If only 1 or 2 row descriptions are needed, then the information should be included as a paragraph instead.

For the not done visit that is now being included in all QRS supplements, when no reason is collected, information should be included, either in the paragraph before, or as a row description as follows:

Rows 49-60:Show the subject was not evaluated on this instrument at visit 2. Since the visit was missed, the reason for not completing the visit was not collected, no date is assumed for when the visit would have occurred.  The following variables --METHOD, EVLINT and EVINTX are also not represented when this happens

When the reason is collected for a not done visit, information or a row description should be added as follows:

Rows 49-60:Show the subject was not evaluated on this instrument at visit 2. Since the reason for not completing the visit was collected, the date is included in --DTC for when the visit was planned.

We are unable to make the example consistently show blue in the Wiki. All examples are updated for each QRS instrument, so we ask that you please review the example below.


The table represents the items from the QRS Short_Name instrument.

Dataset Wrapper Debug Message

Row captions have been provided, but there doesn't seem to be a dataset to which the row captions would apply.

Rows 13-14:Items 11 and 12 are presented for illustrative purposes only. When the instrument is conducted, only one will be represented based on the CRF instructions. In this example, Item 12 would not appear in the actual dataset and has result values of "XXX".
Rows 15-16:Items 13 and 14 are presented for illustrative purposes only. When the instrument is conducted, only one will be represented based on the CRF instructions. In this example, Item 14 would not appear in the actual dataset and has result values of "XXX".
Row 33:The total score does not have an evaluation interval value represented, since there is a mixture of evaluation interval values with items 13 and 14 that differ from the remaining items on the CRF.

Unable to render dataset table

The table contains merged cells. Please unmerge them.

RowSTUDYIDDOMAINUSUBJIDQSSEQQSTESTCDQSTESTQSCATQSORRESQSSTRESCQSSTRESNQSLOBXFLVISITNUMQSDTCQSEVLINT
1STUDYXQS2324-P00011IDSR101IDSR1-Falling AsleepIDS-SRI never take longer than 30 minutes to fall asleep00Y12015-05-15-P7D
2STUDYXQS2324-P00012IDSR102IDSR1-Sleep During the NightIDS-SRI do not wake up at night00Y12015-05-15-P7D
3STUDYXQS2324-P00013IDSR103IDSR1-Waking Up Too EarlyIDS-SRMost of the time, I awaken no more than 30 minutes before I need to get up00Y12015-05-15-P7D
4STUDYXQS2324-P00014IDSR104IDSR1-Sleeping Too MuchIDS-SRI sleep no longer than 7-8 hours/night, without napping during the day00Y12015-05-15-P7D
5STUDYXQS2324-P00015IDSR105IDSR1-Feeling SadIDS-SRI feel sad less than half the time11Y12015-05-15-P7D
6STUDYXQS2324-P00016IDSR106IDSR1- Feeling IrritableIDS-SRI feel irritable less than half the time11Y12015-05-15-P7D
7STUDYXQS2324-P00017IDSR107IDSR1-Feeling Anxious or TenseIDS-SRI feel anxious (tense) less than half the time11Y12015-05-15-P7D
8STUDYXQS2324-P00018IDSR108IDSR1-Your Mood to Good/Desired EventsIDS-SRMy mood brightens but I do not feel like my normal self when good events occur11Y12015-05-15-P7D
9STUDYXQS2324-P00019IDSR109IDSR1-Mood in Relation to Time of DayIDS-SRMy mood often relates to the time of day because of environmental events (e.g., being alone, working)11Y12015-05-15-P7D
10STUDYXQS2324-P000110IDSR109AIDSR1-Mood Worse Morn/Afternoon/NightIDS-SRAfternoonAfternoon
Y12015-05-15-P7D
Rows 11-32 removed for ease of use of template. (fyi, this row has merged cells so don't try to overwrite it when using the template; just delete it.)



33STUDYXQS2324-P000133IDSR131IDSR1-ScoreIDS-SR181818Y12015-05-15

The following is for illustrative purposes and would not really be included for the IDS-SR instrument in this template. It provides an example of what would need to be included if the instrument required supplemental qualifiers (see Section 5 Supplemental Qualifier Name Codes):

Text that would remain unchanged has been left in black:

The evaluation interval text value for data collection needs to be populated in SUPPQS as follows. The standard terminology for QNAM and QLABEL are listed below.

STUDYIDRDOMAINUSUBJIDIDVARIDVARVALQNAMQLABELQVALQORIG
STUDYXQSP0001QSSEQSequence number corresponding to row of qs.xpt that supplemental qualifier is needed for (e.g., 8)Appropriate variable name to provide more information about data in qs.xpt, no more than 8 characters long (e.g., CONTACT).Label for QNAM (e.g., Contact Type)Value of QNAM variable ( e.g., SUBJECT VISIT)CRF

4 SDTM Mapping Strategy

This section is used for reference regarding the CRF data capture and to understand the alignment of the instrument to the SDTM QS domain. It also provides guidance on how the result variables (QSORRES, QSSTRESC, and QSSTRESN) should be populated.

Include mappings for all sets of result values. For ease of use of this template, the complete set of response values for the example in Section 3.2 is not included.

If the instrument has been entered into QRS Maker (all instruments should be), then the complete set of response values can be copied from QRS Maker and pasted into this supplement.

Some example mappings are below.

For QRS instruments with subcategories:

When subcategories are used on an instrument, a table with the following introduction information should appear before the mappings for results.

QSSCAT alignment with QSTESTCD

As stated in Section 3.1 assumptions, items on the QRS Short_Name are grouped into subcategories. The table below includes the subcategory names along with the applicable item numbers for each category. The values of the subcategories are used to populate QSSCAT and are annotated on the CRF.

QSSCATQSTESTCD
EMOTIONAL/INFORMATIONAL SUPPORTQSSS0101 - QSSS0108
TANGIBLE SUPPORTQSSS0109 - QSSS0112
AFFECTIONATE SUPPORTQSSS0113 - QSSS0115
POSITIVE SOCIAL INTERACTIONQSSS0116 - QSSS0118
ADDITIONAL ITEMQSSS0119

For public domain instrument's published QRS responses

  • If this is a public domain instrument that has an individual item with published QRS responses, include the following sentence above the—TESTCDs listed with their responses.

    • The controlled response terminology for the tests below is named --TESTCDOR for the variable RSORRES and --TESTCDSTR for the variables RSSTRESN and RSSTTRESC.

  • If this is a public domain instrument with published QRS responses, include the following sentence above the—TESTCDs listed with their responses.
    • The controlled response terminology for the tests below is named --TESTCDTXXXOR for the variable RSORRES and --TESTCDTXXXTSTR for the variables RSSTRESN and RSSTTRESC.

If all items have the same original result values, with the same standardized character and numeric values, then only include one table showing the values of QSORRES/QSSTRESC/QSSTRESN and put "All QSTESTCDs" (title case "All", and in quotes) above the table:

"All QSTESTCDs"

QSORRESQSSTRESCQSSTRESN
Original result 100
Original result 211
Original result 322

Similarly, if some, but not all, QSTESTCDs share the same original result and standardized values, then the QSTESTCD and corresponding QSTEST values are put in a list above the table rather than providing a separate table for each QSTESTCD/QSTEST.

For public domain instrument's published QRS responses

If this is a public domain instrument with published QRS responses, include the following sentence above the—TESTCDs listed with their responses. This approach used the CDISC QRS CT instrument's SYNONYM as part of the codelist name.

The controlled response terminology for the tests below is named SYNONYMSET1OR for the variable RSORRES and SYNONYMSET1STR for the variables RSSTRESN and RSSTTRESC.

If there are responses that correspond to non-consecutive items or 1-7 consecutive items, include the test codes and test names above the table with the responses as follows:

QSTESTCD = "test code 1" QSTEST = "test name 1"


QSTESTCD = "test code 4" QSTEST = "test name 4"


QSTESTCD = "test code 5" QSTEST = "test name 5"

QSTESTCD = "test code 6" QSTEST = "test name 6"

QSTESTCD = "test code 7" QSTEST = "test name 7"

QSTESTCD = "test code 8" QSTEST = "test name 8"

QSTESTCD = "test code 15" QSTEST = "test name 15"

QSTESTCD = "test code 22" QSTEST = "test name 22"


QSTESTCD = "test code 27" QSTEST = "test name 27"


QSTESTCD = "test code 29" QSTEST = "test name 29"

QSORRESQSSTRESCQSSTRESN
I never take longer than 30 minutes to fall asleep00
I take at least 30 minutes to fall asleep, less than half the time11
I take at least 30 minutes to fall asleep, more than half the time22
I take more than 60 minutes to fall asleep, more than half the time33

Omit the QSSTRESN column when it is not applicable to the dataset.

QSTESTCD = "test code" QSTEST = "test name"

QSORRESQSSTRESC
yesY
noN

For public domain instrument's published QRS responses

If this is a public domain instrument with published QRS responses, include the following sentence above the—TESTCDs listed with their responses.

    • The controlled response terminology for the tests below is named --TESTCDTXXXOR for the variable RSORRES and --TESTCDTXXXTSTR for the variables RSSTRESN and RSSTTRESC.

For responses that are for 8 or more consecutive items, an override label should be used in QRS Maker to show the items that are included as follows:

QSTESTCD = "first test code in sequence" QSTEST = "first test name in sequence" through

QSTESTCD = "last test code in sequence" QSTEST = "last test name in sequence"

QSORRESQSSTRESCQSSTRESN
I have not experienced the physical sensation of feeling weighted down and without physical energy00
I have occasionally experienced periods of feeling physically weighted down and without physical energy, but without a negative effect on work, school, or activity level11
I feel physically weighted down (without physical energy) more than half the time22
I feel physically weighted down (without physical energy) most of the time, several hours per day, several days per week33


5 Supplemental Qualifier Name Codes

The instrument used as an example in this template did not require supplemental qualifiers, but this section has been included to provide guidance on those instruments which do require supplemental qualifiers. (Many instruments do not require it.) Text that always will be in the section when it is included has been left black.

Additional rows will be required in the suppqs.xpt dataset for each supplemental qualifier needed.

Remove Section 5 if it does not apply to the new instrument.

The following table contains additional standard name codes for use in the Supplement Qualifiers for Questionnaires (SUPPQS) special purpose dataset.

QNAMQLABELQVAL
Appropriate variable name to provide more information about data in qs.xpt, no more than 8 characters long (e.g., CONTACT).Label for QNAM (e.g., Contact Type)Value of QNAM ( e.g., SUBJECT VISIT)


End of Document

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